Multicentric Phase II Study to Evaluate Feasibility and Efficacy of Association of Imatinib Mesylate and Zoledronic Acid in Patients With Chronic Myeloid Leukaemia in Cytogenetic Response Without Molecular Response After One Year of Imatinib Mesylate Monotherapy
Inclusion Criteria:
- Inclusion criteria: at registration· Chronic myeloid leukaemia Ph+ confirmed by
cytogenetic analysis or BCR-ABL translocation by molecular biology· Chronic
phase:-<15% blast cells in blood and 5% in bone marrow-<30% blast cells+promyelocyte
cells in blood and bone marrow-<20% basophils in blood->100.000 platelets· Without
extra medullar attempt excepted hepatosplenomagalia· First line of treatment· Biology
and biochemistry with normal levels· Male or female>18 years old· Signed written
consent· ECOG<3At inclusion· Chronic myeloid leukaemia with cytogenetic response
without molecular response after one year of treatment by imatinib and BCR-ABL
transcript detected by RT-PCR
Exclusion Criteria:
- · Other cancer excepted basocellular or cervix carcinoma · Major surgery in last 2
weeks previous inclusion· Women who are pregnant or breastfeeding (are unable to use
an acceptable method to avoid pregnancy of his partner for the entire study period)·
Dementia or altered mental status that would prohibit the understanding or rendering
of informed consent · Abnormal renal function with creatinine clearance < 30
ml/ minuteAccording to Cockcroft-Gault : CrCl= [[140-age (years)] x weight (kg)]/ [72
x serum creatinine (mg/dL)] {x 0.85 for women}· Chronic myeloid leukaemia in
acute phase or in pass to be in acute phase · Treatment with bisphosphonates in last
6 months previous inclusion · Intolerance to bisphosphonates: hypersensitivity, on
course dental problem, including tooth or mandibular infection; dental traumatism or
recent diagnosis or previous mandibular osteonecrosis, or dental extraction with
cicatrisation delay or necessity to set bone evidence · Mandibular surgery in last 6
weeks or planned in the future during treatment (tooth extraction)· Serious
uncontrolled medical disorder or active infection that would impair the ability of
the subject to receive protocol therapy: diabetes, thyroid pathology,
neuropsychiatric illness, myocardial infarction or congestive heart failure grade 3-4
according to " New York Heart association"· History of psychiatric or depressive
pathology · HIV positivity known · Inclusion in other study investigating
antineoplastic molecule in last 30 days previous inclusion